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Are Neutropenic Diets Beneficial to Improve Outcome?
The purpose of this study is to evaluate the infection rate of leukemia patients who eat two different diets. Patients in the "raw" group will eat cooked food and the addition of raw fruits and vegetables. Patients in the "cooked" group will eat only cooked foods and this is the standard neutropenic diet with no fresh fruits or vegetables allowed. The primary objective of the study is to evaluate the infection rate of leukemia patients who eat two different diets. The secondary objectives will be the incidence of fever requiring intravenous antibiotics in each group and death rate.
This study is comparing two different diets. The cooked group will be allowed to eat only cooked food and cooked fruits or vegetables. The raw group will be able to eat cooked food and the addition of fresh fruits and vegetables. Patients will be monitored for infection in both groups. There are still certain foods that you are restricted from eating while receiving chemotherapy and you will be given a list of these restrictions. Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1: Raw group: You will be asked to eat at least 1 raw fruit or vegetable every day you are on study. Group 2: Cooked group: You will eat only cooked foods while on study. The study doctor will give you a list of the foods that you are allowed to eat. Your medical chart will be monitored while you are on study to check how often you need antibiotics to treat fever. or if you have an infection. Diet Questionnaire: You will be asked to fill out a diet questionnaire every week. The questionnaire will have 5 questions about the foods you have been eating. If you have been released from the hospital, you can return the questionnaire during your scheduled hospital visits,which typically take place 3 times per week. You will have no additional visits during this study. The questionnaire should take about 1-2 minutes each time. Length of Study: You will be taken off study if your white blood cell count returns to normal. If your white blood cell counts do not return to normal, the maximum time that you may be on study is 6 weeks. This is an investigational study. There has not been enough research to prove if raw fruits and vegetables can increase your risk of infection. Many hospitals allow neutropenic patients to eat raw fruits and vegetables and other hospitals restrict fresh fruits and vegetables but, this has not been adequately investigated. Up to 128 patients will take part in this study. All will be enrolled at M. D. Anderson.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States
Start Date
July 1, 2009
Primary Completion Date
March 1, 2013
Completion Date
March 1, 2013
Last Updated
June 13, 2014
30
ACTUAL participants
Raw Fruits & Vegetables
OTHER
Cooked Foods
OTHER
Lead Sponsor
M.D. Anderson Cancer Center
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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